MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number	DL-330-3.5-K
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The explanted lead was not returned to neuropace for investigation.
Event or Problem Description
On (b)(6)2025, a review of the patient device ecog data identified signal artifact on the right thalamus (cm) depth lead secured with a dog bone and lead protection.Device assessment included reviewing stored ecogs and palpating the lead connection through the skin, while monitoring live ecog data.A long episode ecog stored on (b)(6) 2024, was when the first clear artifact was noted.On (b)(6) 2025, in clinic, detection was reprogrammed (electrode where artifact was recorded was programmed to 'off').Stimulation parameters were not changed.Although the cause of the lead break is undetermined, the patient reported a seizure on (b)(6) 2024, and this seizure was verified by the device recording of the long episode ecog.The patient has a history of hitting their head during seizures.On (b)(6)2025, the lead was replaced.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 5108822607
• MDR Report Key: 21627644
• Report Number: 3004426659-2025-00018
• Device Sequence Number: 18209326
• Product Code: PFN
• UDI-Device Identifier: 00855547005342
• UDI-Public: 010085554700534217261006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DL-330-3.5-K
• Device Catalogue Number: 1007928
• Device Lot Number: 33748-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Other; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male